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no edit summary
!Description
!Description
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|CAPA_ID
|VARCHAR2(36 CHAR)
|No
|NULL
|ad5e55f6-8b21-ee11-9966-000d3ae86452
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|INSP_ID
|VARCHAR2(36 CHAR)
|No
|NULL
|3d7a309e-ce46-40c5-a6c2-f3ea80971d48
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|INSP_NUM
|VARCHAR2(200 CHAR)
|No
|NULL
|00086-BENEMAX DBA. BENEMAX HEALTH AND WELLNESS
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|OBS_ID
|VARCHAR2(36 CHAR)
|No
|NULL
|07244e35-fbf1-ee11-a1fe-6045bd6005cc
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|CAPA_TYPE
|VARCHAR2(100 CHAR)
|Yes
|NULL
|Follow Up Plan
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|CAPA_PLAN
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|VARCHAR2(2000 CHAR)
|
|Yes
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|NULL
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|February 13, 2024 The company is having the manufacturer of the rescue
kits provide labels. The manufacturer (Physio Control Inc) of the lifepakbatteries felt that they did not need to address the labelling as theywere under the understanding that as a replacement the battery fell underthe original kit.February 19, 2024 The inspector sent follow-up letter to addressPhysio-controls response--the manufacturer can have more than one ID onthe label as long as it clearly marks what the device identifier is andthat this identifier matches what is in the MDALL.March 6, 2024 The company sent follow-up from manufacturer. Themanufacturer has sent in a fax back to Health Canada to include the deviceID (11141-000165) under their license. This adequately addresses theobservation
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|CREATEDBYNAME
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|VARCHAR2(100 CHAR)
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|Yes
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|NULL
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|Jeff Tyndall
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|CREATEDON
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|DATE
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|Yes
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|NULL
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|22-08-26
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|MODIFIEDBYNAME
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|VARCHAR2(100 CHAR)
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|Yes
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|NULL
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|Jeff Tyndall
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|MODIFIEDON
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|DATE
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|Yes
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|NULL
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|22-08-26
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|}
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